First Regimen Combining Long Acting Injectable Antiretrovirals; 32-Week LATTE 2 Study Results Presented at CROI

Cork, Ireland (ots/PRNewswire) -

Intramuscular 2-drug maintenance therapy demonstrates comparable
antiviral activity to daily oral 3-drug combination

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, (Janssen) announced 32-week data from
an ongoing phase IIb study. A regimen of two investigational long
acting, intramuscular (IM) formulations of HIV medicines-Janssen's
rilpivirine and ViiV Healthcare's cabotegravir-given together every 4
or 8 weeks-show comparable antiviral activity to 3-drug oral
antiretroviral therapy (ART) (investigational cabotegravir and two
nucleoside reverse transcriptase inhibitors (NRTIs). The full results
of the study, named LATTE-2, co-funded by Janssen and ViiV Healthcare
were presented at this year's Conference on Retroviruses and
Opportunistic Infections (CROI) in Boston, Massachusetts today.

(Logo: http://photos.prnewswire.com/prnh/20160223/336306LOGO )

The LATTE-2 study is investigating the safety and efficacy of
2-drug IM ART, relative to 3-drug oral ART when used to maintain
viral suppression in HIV-1 infected adults.[1]

Virologic responses (plasma HIV-1 RNA <50 c/ml by FDA snapshot
analysis) for 309 patients at 32 weeks receiving two drug maintenance
therapy with investigational long acting cabotegravir (CAB LA) and
long acting rilpivirine (RPV LA) whether dosed every 8 weeks (Q8W,
95%) or every 4 weeks (Q4W, 94%) were comparable to the response
observed in patients continuing with a three-drug oral regimen of
investigational CAB + NRTIs (91%). Patients switching to CAB LA and
RPV LA administered Q4W reported more adverse events (AEs) leading to
withdrawal (5%; n=6) compared with those receiving an injection Q8W
(2%; n=2) or those who continued on oral CAB + NRTIs (2%, n=1). The
most common AE reported by patients was injection site pain (92% of
injection recipients).[1]

LATTE-2 (31LB) is a phase IIb, multicentre, parallel group, and
open-label study which recruited ART-naïve HIV-infected adults.
Enrolled patients who had a plasma HIV-1 RNA, <50 c/ml during 20-week
Induction Period (IP) with daily oral CAB 30 mg + ABC/3TC were
randomised 2:2:1 to IM CAB LA + RPV LA every four weeks, every 8
weeks, or remained on oral CAB + ABC/3TC (PO) in the Maintenance
Period (MP). The primary endpoints evaluated antiviral activity by
FDA snapshot algorithm, protocol defined virologic failure, and
safety at 32 weeks in the MP.[1]

If successfully developed and approved by regulatory authorities,
this regimen could offer adult patients living with and treated for
HIV an option to maintain viral suppression with 6 or 12 long acting
injections of each drug per year.

"Through scientific advances, over the past two decades, HIV has
moved from a death sentence to a manageable chronic disease," says
Wim Parys, M.D., Vice President and Head of Research and Development
Global Public Health, Janssen. "Results of the LATTE-2 study show
that long acting injectable drug formulations may offer an important
option for HIV maintenance therapy and we remain committed to
developing such combinations as we enter phase 3 studies."

Driven by a purpose of caring, and remaining committed to the
prevention, detection, education and treatment of HIV, Janssen has a
long history in the global battle against HIV/AIDS. It is estimated
that around 37 million people are currently living with HIV globally,
with 2 million people becoming newly infected each year[2]. As a
company, Janssen has a deep commitment to HIV and the company's
ultimate goal is to help all those living with the virus to achieve
an undetectable viral load and have an improved quality of life with
the aim of making HIV history.

About EDURANT® (Rilpivirine)

EDURANT® (rilpivirine) is a prescription HIV medicine that is used
with other antiretroviral medicines to treat Human Immunodeficiency
Virus-1 (HIV-1) in patients:

- Who have never taken HIV medicines before, and
- Who have an amount of HIV in their blood (called "viral load") that
is no more than 100,000 copies/mL. Your healthcare professional
will measure your viral load

EDURANT® should be taken in combination with other HIV medicines.
Your healthcare professional will work with you to find the right
combination of HIV medicines.

It is important that you remain under the care of your healthcare
professional during treatment with EDURANT®.

EDURANT® is not recommended for patients less than 12 years of age

EDURANT® does not cure HIV infection or AIDS. You should remain on
your HIV medications without stopping to ensure that you control your
HIV infection and decrease the risk of HIV-related illnesses. Ask
your healthcare professional about how to prevent passing HIV to
other people.

Please read Important Safety Information
(http://www.edurant.com/patients/important-safety-information), and
talk to your healthcare professional to learn if EDURANT® is right
for you.

About cabotegravir

Cabotegravir is an investigational integrase strand inhibitor
(INSTI) and analogue of dolutegravir (TIVICAY®). Cabotegravir is
being developed by ViiV Healthcare for the treatment and prevention
of HIV and is currently being evaluated as a once-daily oral tablet
formulation and as a LA nanosuspension formulation for intramuscular
(IM) injection.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

Janssen Sciences Ireland UC is one of the Janssen Pharmaceutical
Companies of Johnson & Johnson. At Janssen, we are dedicated to
addressing some of the most important unmet medical needs in
oncology, immunology, neuroscience, infectious diseases and vaccines,
and cardiovascular and metabolic diseases. Driven by our commitment
to patients, we develop innovative products, services and healthcare
solutions to help people throughout the world. More information about
Janssen can be found at: http://www.janssen.com.

Delivering Sustainable Impact in Global Public Health

Combatting HIV is an important component of Johnson & Johnson's
long-standing legacy of commitment and partnership to improve global
public health for individuals, families and communities worldwide.
Janssen supports this commitment with groundbreaking science and
innovative strategies to improve access to medicines, foster
collaborations, and support public health solutions to sustainably
advance health care worldwide.

Through Johnson & Johnson's global public health organization, the
company aims to deliver integrated evidence-based solutions to
address comprehensive health needs and deliver meaningful and
enduring impact in three core focus areas: HIV, maternal and child
health, and extensively drug-resistant (XDR)- and Multidrug-resistant
(MDR)- tuberculosis (TB).

References

1. Margolis DA, González-García J, Stellbrink HJ, et al.
Cabotegravir+rilpivirine as long-acting maintenance therapy:
LATTE-2 week 32 results. Presentation at Conference on
Retroviruses and Opportunistic Infections (CROI), Boston, MA, USA;
22-25 February 2016: abstract 31LB.
2. World Health Organization. HIV/AIDS Fact sheet N°360, updated
November 2015. Available at:
http://www.who.int/mediacentre/factsheets/fs360/en/. Last accessed
February 2016.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development. The reader is cautioned not to rely on
these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections of Janssen Sciences Ireland UC and/or
Johnson & Johnson. Risks and uncertainties include, but are not
limited to: challenges and uncertainties inherent in new product
development, including uncertainty of clinical success and obtaining
regulatory approvals; competition, including technological advances,
new products and patents attained by competitors; challenges to
patents; changes to applicable laws and regulations, including global
health care reforms; and trends toward health care cost containment.
A further list and description of these risks, uncertainties and
other factors can be found in Johnson & Johnson's most recent Annual
Report on Form 10-K, including in Exhibit 99 thereto, and the
company's subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at
http://www.sec.gov, http://www.jnj.com or on request from Johnson &
Johnson. None of the Janssen Pharmaceutical Companies or Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.

ots Originaltext: Janssen Sciences Ireland UC
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Daniel De Schryver
+49 173 76 89 149
ddschryv@its.jnj.com
Ronan Collins (EU)
+47 488 425 00
rcollin5@its.jnj.com
Investor Contacts:
Louise Mehrotra
+1 (732) 524-6491
Lesley Fishman
+1 (732) 524-3922